PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE TABLETS, USP 35 mg Rx Only
Approved
Approval ID
05bb0569-4eed-2139-e063-6394a90acb6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phendimetrazine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-3509
Application NumberANDA040762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB